Most patients encounter shots and injections, like the flu vaccine, in the context of a clinic or local pharmacy. However, for many patients, shots and injections are not an annual occurrence but are required frequently and, as a result, need to be self-administered at home. Biologic drugs haverecently found success addressing chronic diseases but can require at-home administration using prefilled syringes (PFSs) and autoinjectors.

Patients using these self-injection devices can experience psychological challenges ranging from mild squeamishness to extreme anxiety. A recent study of patients with rheumatoid arthritis and Crohn’s disease who used self-injectors highlighted a number of factors, including social perception and emotional state, which influenced the success of using self-injection devices. Incorrect usage of these tools can directly impact a patient’s clinical outcome if they are unable to successfully inject the medication or cause harm through misuse.

In order to address the challenges and risks of patients using self-injection devices at home, Noble International has developed self-injection trainers. These trainers mimic the patient experience with an actual PFS or autoinjector down to very minute details. Increased education and understanding about the injection, as well as physically being able to practice the process of injecting without the pressure of wasting medications or failing to receive medications, allows patients to achieve an increased level of comfort and confidence. In addition to trainers, Noble International is also developing “smart” adherence devices that go one step further in providing real-time feedback that gives patients additional confidence in their injection technique.

To learn more about self-injection as well as Noble International’s line of trainers and “smart” adherence products, Medgadget spoke with Joe Reynolds, Research Manager at Noble International.

Michael Batista, Medgadget: What are some use cases or disease conditions where PFS and autoinjectors are required?

Joe Reynolds: Self-injecting devices such as prefilled syringes and autoinjectors are typically paired with biologics or other large molecule compounds. These are increasingly prescribed for a variety of autoimmune conditions like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis, diabetes, multiple sclerosis and other chronic and acute conditions. In addition, autoinjectors filled with adrenaline and other emergency medications may also be useful as a first-aid measure for severe allergic reactions (anaphylaxis) while waiting for medical assistance to arrive.

Medgadget: Why is it important for patients to work with training devices at home as well as at their physicians’s office? What are some of the risks of improper injection techniques?

Reynolds: When a patient is first prescribed a drug that requires self-injection with an autoinjector or prefilled syringe, they can “learn the ropes” by utilizing a realistic training device in their physician’s office. This builds up the patient’s confidence and also lets the physician, or other specialist, feel comfortable that the patient is ready to use the actual device. Often, however, the patient requires additional training beyond the doctor’s office before they feel completely confident—with extra practice taking place in the comfort of their home. This extra practice is crucial to counter the forgetting curve, which describes how information is naturally lost over a period of time when no attempt is made to retain it. This is especially relevant in light of various studies, including one conducted by Noble, which determined that 84 percent of patients used their autoinjection devices incorrectly prior to training.

It is also important that the patient feels at ease using the trainer on their own, because when the patient has to perform an actual injection without assistance, needle anxiety and unfamiliarity with the device can sometimes be a substantial stumbling block. If patients do not feel completely comfortable with self-injecting, there is a chance they can administer the injection incorrectly. This, in turn, could potentially lead to injury or to injecting less than the entire required dose, which could compromise the effectiveness of the overall treatment, possibly resulting in abandonment of the drug by the patient. Studies have shown patients who used a training device have a reduction in anxiety and an increase in confidence when using the actual device, which in turn could result in better adherence.

Medgadget: Is the concept of at-home self-injection training new? What is the state of the art?

Reynolds: In the past, patients were trained to self-inject using the skin of an orange! Now self-injection trainers are being used because these realistic devices simulate the complete user experience, including device appearance, sound, feel, and functionality.Although the concept of training patients for self-injection at home is not new in itself, an appreciation of the value of extremely realistic training devices is a relatively recent advancement, with pharmaceutical companies integrating training devices and onboarding educational materials in healthcare provider and patient support programs.

Before training devices became a part of best practices within the pharmaceutical industry, traditional educational materials included resources such as instruction videos and Instructions For Use (IFU). Although IFUs have conventionally been included along with medications, research suggests that these are not always as effective as possible in conveying proper usage to patients. Findings suggest many patients who self-administer medication do not read or fully understand the IFU that accompanies their device.In addition to traditional instructions and package inserts, healthcare professionals are typically leveraged as learned intermediaries to onboard patients and provide access to training and education. However, patients are often new to medical terminology and, therefore, sometimes do not fully understand medical instructions. Patients’ inability to recall and utilize information effectively may lead to a higher probability of incorrect administration techniques and errors when using injection devices.

Medgadget: How does Noble improve upon today’s standards?

Reynolds: Noble is really focused on creating realistic training devices with cutting-edge features—and while other companies in the space also offer training devices alongside other products, we are highly specialized and dedicated to developing advanced training device features, several of which are patent pending. We recognized that with a growing market for combination products, such as prescription autoinjectors, there was a largely unmet need.

The mechanical features of our trainers include simulating plunger speed, plunger breakout/glide forces, actuation forces, safety systems, lockout mechanisms, and the forces and feel of an actual injection through specially designed needle tips. In addition, our trainers are fully resettable, so patients can practice multiple times until they feel comfortable self-injecting. Meanwhile, our smart trainers use electronics to detect and monitor each step of a self-injection, wirelessly collecting data as the injection is taking place and providing patients with reminders, error messages, and tutorials that pop up on a phone or tablet. And all of these features are “device agnostic,” meaning they can be incorporated into a variety of self-injection device form factors.

Noble’s latest patient support technology, AdhereIT, builds on innovative trainers and onboarding platforms beyond standard patient training and education. AdhereIT is a smart attachable device component, available for various autoinjector form factors, that connects to the device and has the capability to track, monitor and guide patients not only through device training but also actual self-injections. AdhereIT was developed as an adherence device, which can function with an autoinjector as a standalone technology or can be paired with a smartphone app for further collection of valuable data including training progress, injection history, reminders and more.

To get a better idea of how our trainers may improve the standard of care, we conducted and presented a research study to evaluate the ability of our trainers to prevent user error. Participants in the study were observed during the self-injection process and their errors were tabulated. Across all of the study participants, the fewest errors were made by those patients using error-correcting trainers in conjunction with the IFU. Additionally, 84 percent of those in the study reported they preferred trainers that incorporated error-correcting technology over trainers that did not. Furthermore, self-reported patient confidence increased by 86 percent and anxiety decreased by 15 percent as a result of the use of our trainers.

Medgadget: How has the availability of drug delivery trainers impacted the medical community?

Reynolds: Trainers have made it much easier for healthcare professionals to improve the chances that their patients are utilizing their self-injection devices properly when not under direct supervision. When patients are using their devices properly, they are much more likely to obtain maximum benefit from treatment. This has positive consequences not only for the patients themselves, but also the medical community as a whole, which strives for better patient outcomes.Having these trainers available to healthcare professionals is important for other reasons as well. For example, according to a study by Brod et al., published in the journal Patient Preference and Adherence, a physician’s level of comfort with a treatment’s safety and efficacy plays a key role in their decision to prescribe that treatment. The physician’s enthusiasm, which is conveyed to the patient, is a major factor in determining whether the patient will actually start the treatment. And the physician’s support and continued enthusiasm for the treatment during the first weeks of treatment plays a key role in patient compliance. We believe our trainers can play a key role in enhancing physicians’ level of comfort and enthusiasm regarding the prescribing of self-injection devices to their patients.

Medgadget: Have studies shown a relationship between anxiety, injections, and drug delivery devices?

Reynolds: Yes. For example, a study by Hirai et al., published in the journal of Hepato-gastroenterology, determined that prior to initiation of treatment, 38 percent of Crohn’s disease patients in a multicenter study reported they were unwilling to accept self-injection therapy. Interestingly, after treatment initiation, 75 percent of patients reported being satisfied by the treatment.A separate study Noble-conducted featured several key findings. First, it was found that prefilled syringe trainers with needle simulation technology reduced patients’ anxiety compared to traditional training and no training. Also, 73 percent of patients in the study reported that only having an IFU, and no other training materials, would increase their anxiety. Third, 64 percent reported having a realistic training device to practice with at home would help decrease their anxiety, while 89 percent reported it was very important to have the most realistic training possible. Not only did 69 percent of the patients say it was very important to have a trainer that looks and feels similar to a real needle, but also 87 percent said it was important that the needle tip itself should resemble a real tip. 89 percent of patients also reported a better understanding of a real injection when having a simulated syringe. Meanwhile, a separate study published by Elsevier Science Ireland found that injection anxiety could result in decreased compliance, with 45 percent of patients skipping or avoiding injections due to anxiety or fear.

Medgadget: What are patients saying about the importance of having a training device on hand when beginning a self-injecting regimen?

Reynolds: The feedback has been overwhelmingly positive. In another survey we conducted, 90 percent of self-injection patients rated the value of a realistic training device “7” or higher on a scale of 1 to 10; and in hindsight, 74 percent of patients reported they should have used a trainer. Patients have also stated: “The more realistic to the real thing, the better confidence and success in administering the injection. The feel of it in the hand, ability to hold it, use it. I feel more confident that I would able to use it.”

Another respondent said, “[Training] helps me feel more comfortable with injecting myself if I have something very realistic to practice with first. For me, hands-on training is best. I have a better understanding of what to expect and more confidence in my ability.”

Finally a third patient reported, “[Training] is important because it puts me closer to the actual situation. I have overcome most fear of injection because proper training takes out fear. This was good training [that] helped me to overcome objections on things I was not sure about. Knowledge brings confidence and avoids fear.”

Michael Batista is a Baltimore-based editor motivated by disruptive innovation at the intersection of technology and healthcare. He holds a dual B.S. in materials and bioengineering from MIT and conducted graduate work in biomedical engineering at Johns Hopkins in the Center for Bioengineering Innovation and Design. At Johns Hopkins, Michael was involved in early stage medical technology development before diving into the world of digital healthcare. Since 2014, he has been the CEO of the digital health startup, Quantified Care (https://www.quantifiedcare.com/).

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